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510(k) K853187

Device
ACRIDINE ORANGE FLUORESCENT STAIN
Applicant
ADVANCED MEDICAL TECHNOLOGY, INC.
510(k) number
K853187
Product code
IDC  
Decision
Substantially Equivalent (SESE)
Decision date
1985-08-13
Date received
1985-07-30
Regulation
864.1850
Classification name
Acridine Orange
Medical specialty
Hematology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DAVID A WALL
Address
Suite 502, Perimeter Park 3351 Wrightsboro, Rd. Augusta GA US 30909 30909

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IDC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K812212ACRIDINE ORANGE STAINCarr-Scarborough Microbiologicals, Inc.1981-09-01
K803304ACRIDINE ORANGE STAINRemel Co.1981-02-12
K810040ACRIDINE ORANGE STAINBd Becton Dickinson Vacutainer Systems Preanalytic1981-02-12

Legacy Summary#

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FDA Review#

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